Intuniv is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 6 US drug patents filed from 2013 to 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 04, 2023. Details of Intuniv's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6811794 (Pediatric) | Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles |
Jan, 2023
(1 year, 10 months ago) |
Expired
|
| US6811794 | Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles |
Jul, 2022
(2 years ago) |
Expired
|
|
US6287599 (Pediatric) | Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles |
Jun, 2021
(3 years ago) |
Expired
|
| US6287599 | Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles |
Dec, 2020
(3 years ago) |
Expired
|
|
US5854290 (Pediatric) | Use of guanfacine in the treatment of behavioral disorders |
Mar, 2016
(8 years ago) |
Expired
|
| US5854290 | Use of guanfacine in the treatment of behavioral disorders |
Sep, 2015
(9 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Intuniv's patents.
Latest Legal Activities on Intuniv's Patents
Given below is the list of recent legal activities going on the following patents of Intuniv.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 02 Nov, 2004 | US6811794 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 02 Nov, 2004 | US6811794 (Litigated) |
| Issue Notification Mailed Critical | 14 Oct, 2004 | US6811794 (Litigated) |
| Receipt into Pubs | 06 Oct, 2004 | US6811794 (Litigated) |
| Application Is Considered Ready for Issue Critical | 04 Oct, 2004 | US6811794 (Litigated) |
| Dispatch to FDC | 04 Oct, 2004 | US6811794 (Litigated) |
| Receipt into Pubs | 01 Oct, 2004 | US6811794 (Litigated) |
| Issue Fee Payment Received Critical | 14 Sep, 2004 | US6811794 (Litigated) |
| Issue Fee Payment Verified Critical | 14 Sep, 2004 | US6811794 (Litigated) |
| Receipt into Pubs | 16 Aug, 2004 | US6811794 (Litigated) |
FDA has granted several exclusivities to Intuniv. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Intuniv, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Intuniv.
Exclusivity Information
Intuniv holds 5 exclusivities. All of its exclusivities have expired in 2018. Details of Intuniv's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 02, 2012 |
| New Indication(I-635) | Feb 25, 2014 |
| New Dosing Schedule(D-145) | Nov 19, 2017 |
| M(M-154) | Mar 18, 2018 |
| Pediatric Exclusivity(PED) | May 19, 2018 |
US patents provide insights into the exclusivity only within the United States, but Intuniv is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Intuniv's family patents as well as insights into ongoing legal events on those patents.
Intuniv's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Intuniv's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 04, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Intuniv Generic API suppliers:
Guanfacine Hydrochloride is the generic name for the brand Intuniv. 20 different companies have already filed for the generic of Intuniv, with Twi Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Intuniv's generic
How can I launch a generic of Intuniv before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Intuniv's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Intuniv's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Intuniv -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg, 2 mg, 3 mg and 4 mg | 29 Dec, 2009 | 1 | 05 Oct, 2012 | 04 Jul, 2022 | Eligible |
Alternative Brands for Intuniv
Intuniv which is used for treating attention-deficit hyperactivity disorder., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Lilly |
| |||
About Intuniv
Intuniv is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating attention-deficit hyperactivity disorder. Intuniv uses Guanfacine Hydrochloride as an active ingredient. Intuniv was launched by Takeda Pharms Usa in 2009.
Approval Date:
Intuniv was approved by FDA for market use on 02 September, 2009.
Active Ingredient:
Intuniv uses Guanfacine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Guanfacine Hydrochloride ingredient
Treatment:
Intuniv is used for treating attention-deficit hyperactivity disorder.
Dosage:
Intuniv is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 1MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 4MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 3MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |